Composite device that combines porous metal and bone stimuli

ABSTRACT

An orthopaedic implant for filling voids in bones, and methods of using the same. The orthopaedic implant comprises an open porous metal component, having pores for promoting bone regeneration, and a resorbable bone growth promoting component which is resorbed into new bone. The orthopaedic implant and methods of the present disclosure provide structural support for the bone as well as osteoconductive and/or osteoinductive matrix for promoting bone re-growth within bone void. Advantageously, the orthopaedic implants and methods disclosed herein are useful in filling critically sized bone voids.

CLAIM OF PRIORITY

This application claims the benefit of priority under 35 U.S.C. §119(e)of Monaghan et al., U.S. Provisional Patent Application Ser. No.61/584,460, entitled “COMPOSITE DEVICE THAT COMBINES POROUS METAL ANDBONE STIMULI”, filed on Jan. 9, 2012, which is herein incorporated byreference in its entirety.

BACKGROUND

1. Field of the Disclosure

The present disclosure relates to orthopaedic implants for filling voidsin bones. More particularly, the present disclosure relates toorthopaedic implants having a porous metal component and a resorbablebone growth promoting component for filling voids in bones, and methodsof using the same.

2. Description of the Related Art

Bone voids may result for a number of reasons. For example, jointinjuries or disease may result in the formation of defects and voids ina bone. Additionally, many surgical procedures require drilling intobone, thereby creating bone voids. Further, the locations at which bonevoids occur, and the size of bone voids, are patient specific.

In some cases, a bone void may be so large that the natural bone isunable to fill the void naturally. Such a void is referred to as a“critical size” bone void, and may lead to functional impairment of thebone. The critical size for a bone void is dependent on the patient andthe location at which the bone void occurs. Thus, the use of standardimplants for filling bone voids, especially critical size bone voids,may not be possible.

SUMMARY

The present disclosure relates to orthopaedic implants and methods ofutilizing the same for filling voids in bones. The orthopaedic implantsand methods of the present disclosure provide structural support for thebone, as well as an osteoconductive and/or osteoinductive matrix forpromoting bone re-growth within bone voids. Advantageously, theorthopaedic implants and methods disclosed herein are useful in fillinguniquely-shaped and critically-sized bone voids.

According to an embodiment of the present disclosure, an orthopaedicimplant for treating a bone void is provided. The orthopaedic implantincludes an open porous metal component and a resorbable bone growthpromoting component. The porous metal component includes a first porousmetal layer spaced apart from a second porous metal layer. This spacingcan include a first layer of the resorbable bone growth promotingcomponent situated between the two porous metal layers. For example, thefirst layer of the resorbable bone growth component can contact both thefirst and second porous metal layers although this sort of arrangementof layers is not necessary to broader aspects of the disclosure. In someembodiments, the first and the second porous metal layers of the porousmetal component comprise a coefficient of friction which is greater thanthe resorbable bone growth promoting component and greater thanmammalian bone tissue. Additionally, the orthopaedic implant can includean implantable prosthesis with an elongate stem component that traversesthe first porous metal layer and the second porous metal layer such thatthe first porous metal layer and the second porous metal layer aregenerally transverse to a longitudinal axis of the elongate stemcomponent. In some aspects, the elongate stem component will include anopen porous metal outer surface that can contact portions of the porousmetal layers.

In another embodiment, the present disclosure provides an orthopaedicimplant that incorporates an implantable prosthesis and athree-dimensional augment body. The augment body provides an elongatepassage into which an elongate stem component of the implantableprosthesis can be received for augmenting the implantable prosthesis.Additionally, the augment body incorporates a plurality of stackedlayers which includes a first open porous metal layer, a second openporous metal layer, and a resorbable bone growth-promoting layer that issituated between the first open porous metal layer and the second openporous metal layer. In some aspects, a top face of the resorbable bonegrowth-promoting layer contacts a bottom face of the first open porousmetal layer, and a bottom face of the resorbable bone growth-promotinglayer contacts a top face of the second open porous metal layer.

In another embodiment, the present disclosure provides a method ofimplanting an orthopaedic implant. In this particular method, athree-dimensional augment body is positioned in a bone with an elongatestem component of an implantable prosthesis received in an elongatepassage in the augment body. The augment body incorporates a pluralityof stacked layers which includes a first open porous metal layer spacedfrom a second open porous metal layer. The elongate stem component,which in some aspects can include an open porous metal outer surface,traverses the first open porous metal layer and the second open porousmetal layer. In some forms, one or more resorbable bone growth-promotinglayers are situated between the first open porous metal layer and thesecond open porous metal layer. Additionally, the augment body can bepositioned in the bone before, after, or concurrently as the elongatestem component of the implantable prosthesis is received in the elongatepassage.

In another embodiment, the present disclosure provides a method ofimplanting an orthopaedic implant. In one step, a multilayered malleablesheet is positioned in a bone void with a first face of the malleablesheet contacting walls of the bone void and a second face of themalleable sheet remaining exposed for contacting an implantableprosthesis that is subsequently implantable adjacent the bone void. Themultilayered malleable sheet incorporates a first open porous metallayer spaced from a second open porous metal layer. In another step, animplantable prosthesis is located adjacent the bone void so as tocontact the exposed second face of the malleable sheet. One or moreresorbable bone growth-promoting layers can be situated between and/orto either side of each of the first open porous metal layer and thesecond open porous metal layer.

According to another embodiment of the present disclosure, anorthopaedic implant is provided. The orthopaedic implant includes amonolithic open porous metal body having a plurality of channels thereinand an exposed porous exterior surface for contacting bone. Theorthopaedic implant also includes a resorbable bone growth promotingcomponent which comprises an osteoconductive carrier, and at least onebone growth factor. Further, the resorbable bone growth promotingcomponent is disposed within the channels of the monolithic open porousmetal body of the orthopaedic implant. In some embodiments, theresorbable bone growth promoting component substantially fills thechannels of the monolithic open porous metal body.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing description of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is an enlarged cross-sectional view of the structure of an openporous metal component according to the instant disclosure;

FIG. 2 is an enlarged cross-sectional view of the open porous metalcomponent of FIG. 1 being combined with one or more bone growth factors;

FIG. 3 is a perspective view illustrating an embodiment of anorthopaedic implant according to the present disclosure comprisingindividual layers of the open porous metal component stacked betweenindividual layers of the resorbable bone growth promoting component;

FIG. 4 is a cross-sectional view showing the orthopaedic implant of FIG.3 being combined with one or more bone growth factors;

FIG. 5 a is a cross-sectional view illustrating an orthopaedic implantaccording to the present disclosure implanted within a void in a femur;

FIG. 5 b is an enlarged view of the orthopaedic implant implanted withinthe bone void of FIG. 5 a;

FIG. 6 a is a cross-sectional view illustrating an orthopaedic implantaccording to the present disclosure implanted within a void in anacetabulum;

FIG. 6 b is an enlarged view of the orthopaedic implant implanted withinthe void of FIG. 6 a;

FIG. 7 is a cross-sectional view of another embodiment of an orthopaedicimplant according to the present disclosure comprising an augment orsupport structure for a tibial baseplate implanted within theintramedullary canal of a tibia;

FIG. 8 is a cross-sectional view of yet another embodiment of anorthopaedic implant according to the present disclosure comprising anaugment or support structure for a femoral prosthesis implanted withinthe femoral canal of a femur;

FIG. 9 a is a perspective view of another embodiment of an orthopaedicimplant according to the present disclosure for use with a distalfemoral prosthesis; and

FIG. 9 b is an enlarged perspective view of another embodiment of theorthopaedic implant of FIG. 9 a.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

Introduction.

The present disclosure generally relates to orthopaedic implants forfilling voids in bones and methods of utilizing the orthopaedic implantsdisclosed herein. The orthopaedic implants disclosed herein comprise anopen porous metal component and a resorbable bone growth promotingcomponent. Further, the orthopaedic implants disclosed herein providestructural support for the bone as well as an osteoconductive and/orosteoinductive matrix for promoting bone re-growth within the bone void.Advantageously, the orthopaedic implants disclosed herein may be used tofill critically sized bone voids.

Open Porous Metal Component.

1. Structure of Open Porous Metal Component.

The orthopaedic implants disclosed herein are comprised, in part, ofopen porous metal component 100 (FIG. 1). According to some embodimentsof the orthopaedic implants disclosed herein, open porous metalcomponent 100 may comprise all, or a substantial portion of, theimplant. As described herein, open porous metal component 100 providesstructural support to the orthopaedic implants and to the bone, within abone void. Additionally, open porous metal component 100 comprises oneor more exposed porous metal surfaces 110 which, as described herein,are particularly suited for contacting bone and for promoting boneingrowth therein.

Referring to FIG. 1, an illustrative embodiment of open porous metalcomponent 100 is depicted. As shown, open porous metal component 100generally includes a large plurality of ligaments 102 defining openvoids (i.e., pores) or channels 104 therebetween. The open voids betweenligaments 102 form a matrix of continuous channels 104 having few or nodead ends, such that growth of bone through open porous metal component100 is substantially uninhibited. Open porous metal component 100 mayinclude up to 75%-85% or more void space therein. Thus, open porousmetal component 100 may comprise a lightweight, strong porous structurewhich is substantially uniform and consistent in composition, andprovides a matrix into which bone may grow.

According to some configurations of the instant disclosure, open porousmetal component 100 of the orthopaedic implants disclosed herein maycomprise at least one exposed porous metal surface 110. As shown in FIG.1, the terminating ends of ligaments 102, referred to herein as struts150, define exposed porous metal surface 110. Struts 150, comprisingexposed porous metal surface 110, generate a high coefficient offriction when in contact with bone and other tissue. Further, struts 150impart an enhanced affixation ability to exposed porous metal surface110, thereby aiding in the initial fixation (upon implantation) of theorthopaedic implant to bone or other tissue.

Open porous metal component 100 may be made of a highly porousbiomaterial useful as a bone substitute and/or cell and tissue receptivematerial. For example, according to embodiments of the instantdisclosure, open porous metal component 100 may have a porosity as lowas 55%, 65%, or 75% or as high as 80%, 85%, or 90%. An example of openporous metal component 100 is produced using Trabecular Meta1™Technology generally available from Zimmer, Inc., of Warsaw, Ind.Trabecular Meta1™ is a trademark of Zimmer, Inc. Such a material may beformed from a reticulated vitreous carbon foam substrate which isinfiltrated and coated with a biocompatible metal, such as tantalum, bya chemical vapor deposition (“CVD”) process in the manner disclosed indetail in U.S. Pat. No. 5,282,861, entitled OPEN CELL TANTALUMSTRUCTURES FOR CANCELLOUS BONE IMPLANTS AND CELL AND TISSUE RECEPTORS,and in Levine, B. R., et al., “Experimental and Clinical Performance ofPorous Tantalum in Orthopedic Surgery”, Biomaterials 27 (2006)4671-4681, the disclosures of which are expressly incorporated herein byreference. In addition to tantalum, other metals such as niobium oralloys of tantalum and niobium with one another or with other metals mayalso be used. Further, other biocompatible metals, such as titanium, atitanium alloy, cobalt chromium, cobalt chromium molybdenum, tantalum,or a tantalum alloy may also be used.

Additionally, embodiments of open porous metal component 100 maycomprise a Ti-6Al-4V ELI alloy, such as Tivanium® Alloy which isavailable from Zimmer, Inc., of Warsaw, Ind. Tivanium® is a registeredtrademark of Zimmer, Inc. Open porous metal component 100 may alsocomprise a fiber metal pad or a sintered metal layer, such as a CSTi™,Cancellous-Structured Titanium™ coating or layer, for example. CSTi™porous layers are manufactured by Zimmer, Inc., of Warsaw, Ind. CSTi™ isa trademark of Zimmer, Inc.

In other embodiments, open porous metal component 100 may comprise anopen cell polyurethane foam substrate coated with Ti-6Al-4V alloy usinga low temperature arc vapor deposition process. Ti-6Al-4V beads may thenbe sintered to the surface of the Ti-6Al-4V-coated polyurethane foamsubstrate. Additionally, another embodiment of open porous metalcomponent 100 may comprise a metal substrate combined with a Ti-6AL-4Vpowder and a ceramic material, which is sintered under heat andpressure. The ceramic particles may thereafter be removed leaving voids,or pores, in the substrate. Open porous metal component 100 may alsocomprise a Ti-6Al-4V powder which has been suspended in a liquid andinfiltrated and coated on the surface of a polyurethane substrate. TheTi-6Al-4V coating may then be sintered to form a porous metal structuremimicking the polyurethane foam substrate. Further, another embodimentof open porous metal component 100 may comprise a porous metal substratehaving particles, comprising altered geometries, which are sintered to aplurality of outer layers of the metal substrate.

Additionally, open porous metal component 100 may be fabricatedaccording to electron beam melting (EBM) and/or laser engineered netshaping (LENS). For example, with EBM, metallic layers (comprising oneor more of the biomaterials, alloys, and substrates disclosed herein)may be coated (layer by layer) on an open cell substrate using anelectron beam in a vacuum. Similarly, with LENS, metallic powder (suchas a titanium powder, for example) may be deposited and coated on anopen cell substrate by creating a molten pool (from a metallic powder)using a focused, high-powered laser beam.

Open porous metal component 100 may also be fabricated such that itcomprises a variety of densities in order to selectively tailor thestructure for particular applications. In particular, as discussed inthe above-incorporated U.S. Pat. No. 5,282,861, open porous metalcomponent 100 may be fabricated to virtually any desired density,porosity, and pore size (e.g., pore diameter), and can thus be matchedwith the surrounding natural tissue in order to provide an improvedmatrix for tissue ingrowth and mineralization.

2. Bone Growth Promoting Agents for Use in Combination with Open PorousMetal Component.

In addition to comprising selectively tailored densities, porosities,and pore sizes, open porous metal component 100 of the orthopaedicimplants disclosed herein may also be combined with various bone growthfactors or agents. Referring to FIGS. 2 and 4, one or more bone growthfactors or agents may be injected into channels 104 (FIG. 1), withsyringe 120 for example, or applied to one or more exposed porous metalsurfaces 110 of open porous metal component 100. As shown, in someconfigurations open porous metal component 100 may be combined with oneor more growth factors or agents such that the growth factors or agentspartially fill open porous metal component 100. In other configurations,growth factors and agents may substantially fill channels 104 throughoutthe dimensional extent of open porous metal component 100. According toembodiments of the instant disclosure in which the dimensional extent ofopen porous metal component 100 is substantially filled, as low as 35%,40%, or 45% or as high as 85%, 90%, or 95%, or more, of the volumewithin channels 104 of open porous metal component 100 may be filledwith growth factors or agents.

Bone growth factors or agents which may be combined with the orthopaedicimplants disclosed herein include growth factors influencing theattraction, proliferation, differentiation, and organization of all bonecells types such as osteocytes, osteoclasts, osteoblasts, odentoblasts,cementoblasts, and precursors thereof (e.g., stem cells). Additionally,the bone growth factors or agents disclosed herein include growthfactors influencing the attraction, proliferation, differentiation, andorganization of soft tissue cell types such as fibrocytes, chondrocytes,tenocytes, ligament cells, and precursors thereof (e.g., stem cells).Further, the bone growth factors disclosed herein also includeangiogenic factors, such as vascular endothelial growth factor (VEGF)for example.

According to the instant disclosure, exemplary bone growth factors oragents include, but are not limited to, bone morphogenic proteins (BMP)such as BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, transforminggrowth factor (TGF)-β, platelet drived growth factors, and epidermalgrowth factor, for example. Other exemplary bone growth factors oragents which may be combined with the orthopaedic implants disclosedherein include bone proteins, such as osteocalcin, osteonectin, bonesialoprotein, lysyloxidase, cathepsin L, biglycan, fibronextinfibroblast growth factor (FGF), platelet derived growth factor, calciumcarbonate, and thrombospondin (TSP). Additionally, exemplary growthfactors or agents which may be combined with the orthopaedic implantsdisclosed herein may also include fibroblast growth factors (FGF) suchas FGF-I, FGF-II, FGF-9, insulin growth factor (IGF)-I, IGF-II, plateletderived growth factor, epithelial growth factors (EGF), and TGF-α. Inaddition to the bone growth factors described above, the orthopaedicimplants disclosed herein may also be combined with other generalcellular growth factors and with pluripotent cells as well aschondrocytes, in order to further support regeneration of bony tissuewithin the bone voids and throughout the orthopaedic implants. In someembodiments, in addition to or as an alternative to the other exemplaryagents and growth factors described herein, strontium may be combinedwith the disclosed orthopedic implants as an active agent to promotebone growth.

Exemplary combinations or mixtures of bone growth factors and agents,which may be combined with open porous metal component 100 of theorthopaedic implants disclosed herein, may include the mixturesdescribed in U.S. Patent Publication No. 2011/0165199, entitledCOMPOSITION AND PROCESS FOR BONE GROWTH AND REPAIR, the entiredisclosure of which is hereby incorporated by reference. In otherconfigurations, open porous metal component 100 may be combined with themixtures of bone growth factors and agents described in U.S. Pat. No.7,718,616, entitled BONE GROWTH PARTICLES AND OSTEOINDUCTIVE COMPOSITIONTHEREOF, the entire disclosure of which is hereby incorporated byreference. Still other mixtures of bone growth factors and agents whichmay be combined with open porous metal component 100 include thosemixtures described in U.S. Pat. No. 5,290,763, entitled OSTEOINDUCTIVEPROTEIN MIXTURES AND PURIFICATION PROCESSES, the entire disclosure ofwhich is hereby incorporated by reference.

Prior to combining the bone growth factors or agents, and mixturesthereof, with open porous metal component 100, the growth factors andagents may first be combined with, or dissolved within, a suitablecarrier such as a calcium carrier, a phosphate carrier, a ceramiccarrier, or a polylactide co-glycolide (PLGA) carrier. An example of onesuch carrier, as described in greater detail below, includes resorbablebone growth promoting component 200. For example, one or more bonegrowth factors or agents may be combined (e.g., mixed with or dissolvedin) resorbable bone growth promoting component 200, then inserted intochannels 104, or coated on one or more exposed porous metal surfaces110, of open porous metal component 100.

Although open porous metal component 100 of the orthopaedic implantsdisclosed herein may comprise substantially uniform porosity, density,and/or void (pore) size throughout, some configurations may compriseopen porous metal component 100 having at least one of pore size,porosity, and/or density being varied as described in U.S. ProvisionalPatent Application Ser. No. 61/561,475 entitled POROUS METAL DEVICE FORREGENERATING SOFT TISSUE-TO-BONE INTERFACE filed on Nov. 18, 2011(Attorney Docket No. ZIM0899). For example, with reference to FIG. 3which depicts an illustrative orthopaedic implant comprising alternatinglayers of open porous metal component 100′, 100″ stacked (or layered)between alternating layers of resorbable bone growth promoting component200′, 200″, the pore size and/or porosity of the first layer of openporous metal component 100′ may vary from the pore size and/or porosityof the second layer of open porous metal component 100″. Additionally,in some configurations the pore size and/or porosity within a same layerof open porous metal component 100 may vary. The ability to selectivelytailor the structural properties of open porous metal component 100 asdescribed herein, enables the orthopaedic implants of the presentdisclosure to better distribute stress loads throughout the surroundingtissue and promote specific tissue type ingrowth within channels 104(FIG. 1) of open porous metal component 100.

Referring to FIG. 3, open porous metal component 100 may comprise one ormore porous metallic sheets, the sheets being relatively thin (e.g.,having a thickness of as low as two pore diameters to as high as twelveor more pore diameters) and being at least partially flexible. Suchconfigurations allow open porous metal component 100 to be shaped andsized according to a particular application. For example, a surgeon mayshape, cut, bend, or trim open porous metal component 100 to any desiredcustom size and/or shape in order to meet a patient's particular need.As such, open porous metal component 100 advantageously enables asurgeon to utilize the orthopaedic implants disclosed herein to fillunique bone voids having different shapes and sizes and occurring atvarious locations.

Resorbable Bone Growth Promoting Component.

Referring to FIG. 3, the orthopaedic implants disclosed herein comprise,in part, resorbable bone growth promoting component 200. According toembodiments of the orthopeadic implants disclosed herein, resorbablebone growth promoting component 200 may comprise a solid mass, such as apowder (loose or compressed), or a soft mass, such as a putty or paste.Further, resorbable bone growth promoting component 200 comprises anosteoconductive carrier, capable of providing one or more bone growthfactors for aiding the bone regeneration process.

As described herein, resorbable bone growth promoting component 200provides a temporary matrix for cell proliferation andextracellular-matrix deposition with consequent bone ingrowth until newbony tissue regenerates. As explained in the above-incorporated U.S.Pat. No. 7,718,616, during bone regeneration resorbable bone growthpromoting component 200 is resorbed or incorporated into the newlyformed bone. Resorbable bone growth promoting component 200 alsoprovides a template for vascularization of new bony tissue, and mayactively participate in the regenerative process through the release ofgrowth differentiation factors. Additionally, the structural propertiesof resorbable bone growth promoting component 200 influence thesurvival, signaling, growth, propagation, and reorganization of cells.

Embodiments of resorbable bone growth promoting component 200 maycomprise CopiOs° Bone Void Filler which is available from Zimmer, Inc.,of Warsaw, Ind., for example. CopiOs° is a registered trademark ofZimmer, Inc. Resorbable bone growth promoting component 200 may comprisea fibrillar collagen as described in detail in the above-incorporatedU.S. Pat. No. 7,718,616. Fibrillar collagen comprising resorbable bonegrowth promoting component 200 may be obtained from native sources suchas human or animal dermis, tendon, cartilage or bone, and may berecovered through proteolytic degradation of collagen fiber crosslinksas detailed in U.S. Pat. No. 7,718,616. Further, during the manufactureof fibrillar collagen, potential antigenic portions of the collagenmolecule may be removed, resulting in a product that is highlybiocompatible and well-tolerated by host tissue. In such configurations,resorbable bone growth promoting component 200 provides a physical andchemical milieu favorable to bone regeneration by providing a favorableextracellular matrix for bone forming cells (e.g., osteoblasts,osteoclasts, osteocytes, etc.).

Additionally, configurations of resorbable bone growth promotingcomponent 200 may comprise a compound which renders it acidic. Anexample of such a configuration is described in the above-incorporatedU.S. Patent Publication No. 2011/0165199 which describes a configurationof resorbable bone growth promoting component 200 comprising a porouscollagen with a calcium source and/or a phosphate source embeddedtherein. Such configurations of resorbable bone growth promotingcomponent 200 provide a structure for the growth of bone and an acidicenvironment for enhancing the activity of bone growth proteins, therebyinducing and further enhancing the production of bone.

According to the instant disclosure, resorbable bone growth promotingcomponent 200 may comprise various other compositions. For example,resorbable bone growth promoting component 200 may comprise a porouscollagen mix (e.g., type I collagen) having blood and/or bone fragmentsembedded therein. Other embodiments of resorbable bone growth promotingcomponent 200 may comprise a synthetic hydroxylapatite mixture with anexternal negative charge. Still, other embodiments of resorbable bonegrowth promoting component 200, within the scope of the presentdisclosure, may include a resorbable inorganic calcium phosphatecomposition having human fibrin embedded therein. Even furtherconfigurations of resorbable bone growth promoting component 200 maycomprise a synthetic biocompatible sulfate composition.

Referring to FIG. 3, an embodiment ofresorbable bone growth promotingcomponent 200 is shown as a solid mass (a compressed powder). Theconfiguration of resorbable bone growth promoting component 200 shown inFIG. 3 includes two discs or sheets, stacked between two layers orsheets of open porous metal component 100. Resorbable bone growthpromoting component 200 comprises an open pore, fully interconnectedthree-dimensional geometry which allows bone ingrowth. In addition toallowing bone ingrowth, such configurations of resorbable bone growthpromoting component 200 also facilitate vascularization and allow forthe diffusion of nutrients, gases, and metabolic waste during the boneregeneration process.

Although depicted in FIG. 3 as comprising a solid mass (a compressedpowder in the form of two discs), resorbable bone growth promotingcomponent 200 may also comprise a soft mass, such as a sponge or puttyconsistency (having a physical consistency between a liquid and asolid). Resorbable bone growth promoting component 200 may also take theform of a loose (non-compressed) powder which, as is described herein,may be hydrated into a soft mass, or may be hydrated to have a moreliquid-like consistency. When in the form of a soft mass, resorbablebone growth promoting component 200 may be molded to a desired shape andsize, and in some cases may be partially or substantially disposedwithin channels 104 (FIG. 1) of open porous metal component 100.

As described in the above-incorporated U.S. Pat. No. 7,718,616,configurations of resorbable bone growth promoting component 200 mayhave a total pore volume which is similar to cancellous bone. Cancellousbone is a highly porous structure (having a pore volume from as low asapproximately 50 volume % to as high as approximately 97 volume %)arranged in a sponge-like form, with pore diameters ranging from as lowas 1 μm to as high as approximately 1000 μm. Thus, according toconfigurations of the orthopaedic implants disclosed herein, resorbablebone growth promoting component 200 may comprise a total pore volume aslow as 50, 55, or 60% to as high as 80, 90, or 97% or any value therebetween. Further, resorbable bone growth promoting component 200 maycomprise pore diameters as small as approximately 0.5, 1, or 2, to ashigh as 800, 900, or 1000 μm, or any value there between.

Further, resorbable bone growth promoting component 200 also comprisesan osteoconductive carrier for one or more bone growth factors or agentsas detailed in the above-incorporated U.S. Pat. No. 7,718,616. Forexample, with reference to FIG. 4, syringe 120 may be utilized to injectone or more bone growth factors or agents within channels 104 of openporous metal component 100. In some configurations, the growth factorsand agents will reach resorbable bone growth promoting component 200,where they are wicked or absorbed by resorbable bone growth promotingcomponent 200. Resorbable bone growth promoting component 200 of someconfigurations of the orthopaedic implant described herein may wick (orabsorb) greater than seven times its weight. Additionally, upon wickingthe growth factors or agents, the form of resorbable bone growthpromoting component 200 may be altered (e.g., change from a solid massto a soft mass). Further, although bone growth factors or agents areshown in FIG. 4 being injected into the orthopaedic implant it should beunderstood that the orthopaedic implant may be dipped or soaked into amixture of bone growth factors or agents as well.

As disclosed in the above-incorporated U.S. Pat. No. 7,718,616, thecomposition and the physical characteristics of resorbable bone growthpromoting component 200 may affect the rate of elution of the growthfactors and other agents combined with the resorbable bone growthpromoting component 200. For example, as explained in U.S. Pat. No.7,718,616, cross-linking of materials (e.g., collagen) comprisingresorbable bone growth promoting component 200, the pore size, and theporosity of resorbable bone growth promoting component 200 may allaffect the release of growth factors or agents combined therewith.

Additionally, according to some configurations, a polymer-based and/or areceptor-based system may be utilized in conjunction with resorbablebone growth promoting component 200 for controlling the rate of elutionand localization of the growth factors and other agents. For example,the growth factors or agents combined with resorbable bone growthpromoting component 200 may be encapsulated within a polymer-basedcoating, or combined with a polymer-based matrix, before being combinedwith the resorbable bone growth promoting component 200. Similarly, aligand (such as a protein, antibody, or portion thereof, for example)may be attached to the growth factor or agent as well. As such, inaddition to the physical characteristics of resorbable bone growthpromoting component 200, release of the growth factors or agents from apolymer-based coating (or matrix), and/or targeting of a ligand(attached to the growth factors or agents), may also affect the rate ofelution and localization of the growth factors and agents fromresorbable bone growth promoting component 200.

In addition to the exemplary growth factors and agents already describedherein, resorbable bone growth promoting component 200 may also becombined with the mixtures of various bone growth factors or agents,such as described in U.S. Patent Publication No. 2011/0165199, forexample. Additionally, in some configurations, resorbable bone growthpromoting component 200 may be combined with the mixtures of variousbone growth factors or agents described in U.S. Pat. No. 7,718,616.Other mixtures of bone growth factors or agents which may be combinedwith resorbable bone growth promoting component 200 include thosemixtures described in U.S. Pat. No. 5,290,763.

Additionally, in some configurations of the orthopaedic implantsdescribed herein, resorbable bone growth promoting component 200 may becombined with biological fluids such as bone marrow aspirates. Asexplained in U.S. Pat. No. 7,718,616, bone marrow aspirates containosteoinductive agents such as mesenchymal stem cells which aremulti-potent cells capable of differentiating along several lineagepathways to aid in the production of bone. Other exemplary biologicalfluids which may be combined with resorbable bone growth promotingcomponent 200 include blood, plasma, serum, and bone marrow. In additionto biological fluids, resorbable bone growth promoting component 200 mayalso be combined with a buffer, such a buffer capable of buffering tothe physiological pH values of human serum (pH 7.1 to pH 7.4), forexample.

Further, in some configurations resorbable bone growth promotingcomponent 200 may also be combined with osteoinductive bone componentsincluding demineralized bone and autologous bone. As explained in U.S.Pat. No. 7,718,616, demineralization may be performed, for example, byexposing powdered bone (from any human or mammalian source) to acidicsolutions (i.e., HCl, acetic acid, ethylene diamine tetracetic acid)with a pH less than about 4. Further, bone which has not beendemineralized may also be included in resorbable bone growth promotingcomponent 200.

Even further, in addition to the liquid compositions already disclosedherein, resorbable bone growth promoting component 200 may also becombined with natural and/or synthetic polymers such as described in theabove-incorporated U.S. Patent Publication No. 2011/0165199. Exemplarynatural and synthetic polymers which may be combined with resorbablebone growth promoting composition 200 include aliphatic polyesters,polyethylene glycols, polyanhydrides, dextran polymers, and/or polymericorthophosphates.

As discussed in greater below, the orthopaedic implants disclosed hereinmay have various configurations. Additionally, open porous metalcomponent 100 and resorbable bone growth promoting component 200,comprising the orthopaedic implants described herein, may have variousdimensions. For example, in configurations of the orthopaedic implantscomprising layers, each layer of open porous metal component 100 maycomprise a thickness of as low as approximately 1, 2, or 3 mm, to ashigh as approximately 6, 7, or 8 mm. Likewise, each layer of resorbablebone growth promoting component 200 may also comprise a thickness of aslow as approximately 1, 2, or 3 mm, to as high as approximately 6, 7, or8 mm, for example. Further, the orthopaedic implants describe herein maybe dimensioned such that, when implanted, the orthopaedic implants mayfill a critical size bone void (for example, a void of greater than 7mm), and new bone will grow throughout all layers comprising theorthopaedic implant.

Exemplary Bone Void Implant Embodiments of Orthopaedic Implants.

Referring to FIGS. 5 a and 6 a, illustrative embodiments of orthopaedicimplant 500, 500′ being used to fill a void V in a bone B are shown. Asdepicted, orthopaedic implant 500 may fill a void V in a bone B prior toimplantation of a prosthesis P within bone B. Further, theconfigurations of orthopaedic implant 500, 500′ shown in FIGS. 5 a and 6a include open porous metal component 100 and resorbable bone growthpromoting component 200 both comprising multiple, alternating layers,such as shown in FIG. 3.

Referring to FIGS. 5 a and 5 b, orthopaedic implant 500 is shown fillingvoid V adjacent canal C in proximal femur bone B. As shown, orthopaedicimplant 500 comprises a first layer of open porous metal component 100′having a first layer of resorbable bone growth promoting component 200′stacked or layered thereon. Orthopaedic implant 500 also include asecond layer of open porous metal component 100″ layered on the firstlayer of resorbable bone growth promoting component 200′, and a secondlayer of resorbable bone growth promoting component 200″ layered on thesecond layer of open porous metal component 100″.

With reference to FIG. 5 b, orthopaedic implant 500 is configured tocompletely fill void V, within bone B, adjacent prosthesis P. Furtherorthopaedic implant 500 may be orientated in void V such that exposedporous surface 110 of open porous metal component 100′ contacts bone Boutlining void V. As described in detail above, struts 150 comprisingexposed porous surface 110 of open porous metal component 100′ provide acoefficient of friction which aides in providing initial fixation oforthopaedic implant 500 to bone B. Further, exposed porous surface 110allows for ingrowth of bone in the plurality of pores 104.

While orthopaedic implant 500 is depicted as having open porous metalcomponent 100′ contacting bone B outlining void V, and resorbable bonegrowth promoting component 200″ contacting prosthesis P, variousconfigurations of the layers comprising orthopaedic implant 500 arepossible. Additionally, in some configurations orthopaedic implant 500,may include one or more additional layers, such as a bone cement layer,which contacts prosthesis P and provides initial fixation betweenorthopaedic implant 500 and prosthesis P. Further embodiments oforthopaedic implant 500 are possible in which prosthesis P may alsocomprise an open porous metal, thereby allowing for fixation oforthopaedic implant 500 to prosthesis P, by way of regenerated bone.

Referring to FIGS. 6 a and 6 b, a configuration of orthopaedic implant500′ being used to fill void V in an acetabulum bone B is depicted. Asshown, orthopaedic implant 500′ may be used to fill a void V in a bone Bprior to affixation of acetabular cup prosthesis P to bone B.

The configuration of orthopaedic implant 500′ depicted in FIGS. 6 a and6 b comprises three layers of each of open porous metal component 100and resorbable bone growth promoting component 200, arranged inmultiple, alternating layers (similar to the configuration oforthopaedic implant 500 depicted in FIGS. 5 a and 5 b). As shown inFIGS. 6 a and 6 b, orthopaedic implant 500′ has been shaped tocompletely fill void V, within bone B, adjacent prosthesis P. Forexample, as can be seen in FIGS. 6 a and 6 b, layers of orthopaedicimplant 500′ adjacent prosthesis P may be reamed or trimmed to create anaperture therein such that orthopaedic implant 500′ completely fillsvoid V.

Similar to configurations of orthopaedic implant 500, shown in FIG. 5 b,FIG. 6 b depicts orthopaedic implant 500′ being orientated in void Vsuch that exposed porous surface 110 of open porous metal component 100contacts bone B outlining void V. While depicted as having a layer ofopen porous metal component 100 contacting bone B, configurations oforthopaedic implant 500′ may have resorbable bone growth componentcontacting bone B. Additionally, embodiments of orthopaedic implant 500′may also include an additional layer such as bone cement contactingprosthesis P and spacing (at least partially) orthopaedic implant 500′from the prosthesis P. Further, as with orthopaedic implant 500, in someconfigurations prosthesis P comprises an open porous metal, therebyallowing for fixation of orthopaedic implant 500′ to prosthesis P, byway of regenerated bone.

Referring again to both FIGS. 5 a and 6 a, the illustratedconfigurations of orthopaedic implant 500, 500′ may be combined withvarious bone growth factors or agents, as discussed herein. For example,a configuration of orthopaedic implant 500 may include a mixture of oneor more bone growth factors coated along one or more exposed poroussurface 110 of one or more layer of open porous metal component 100.Additionally, configurations of orthopaedic implant 500, 500′ mayinclude one or more bone growth factors disposed within channels 104 ofone or more layers of open porous metal component 100. Further, asdisclosed herein, in some configurations one or more layers ofresorbable bone growth promoting component 200 may also be combined withone or more bone growth factors or agents.

While resorbable bone growth promoting component 200 is shown as a solidmass (compressed powder), configurations of orthopaedic implant 500,500′ may comprise resorbable bone growth promoting component 200 in theform of a soft mass, such as a sponge, paste, or putty, for example.Also, in addition to separating (or spacing) the individual layers ofopen porous metal component 100 (e.g., layers 100′ and 100″ shown inFIG. 5 b), one or more of the layers of resorbable bone growth promotingcomponent 200 may also be partially disposed within at least a portionof one or more exposed porous surfaces 110 of open porous metalcomponent 100 (such as shown in FIG. 4).

In use, the configurations of orthopaedic implant 500, 500′ shown inFIGS. 5 b and 6 b, may be shaped and sized according to a particularapplication. For example, a surgeon may shape, cut, bend, or trim one ormore of the layers of open porous metal 100 and/or resorbable bonegrowth promoting component 200 to any desired custom size and shape inorder to meet a particular need. Shaping and sizing of open porous metalcomponent 100 and resorbable bone growth promoting component 200 mayoccur prior to, or after, arranging orthopaedic implant 500, 500′ in thelayered or stacked configuration depicted in FIGS. 5 b and 6 b, forexample. As such, orthopaedic implant 500, 500′ may be used to fillunique bone voids having different shapes and sizes and occurring atvarious patient specific locations.

Additionally, when implanted, the configurations of orthopaedic implant500, 500′ shown in FIGS. 5 a and 6 a promote new bone regeneration,while providing initial structural support and fixation within void V.As detailed above, resorbable bone growth promoting component 200provides a temporary matrix for cell proliferation and extracellularmatrix deposition, which also promotes vascularization for supportingcontinued bone regeneration and maintenance. As new bone is regenerated,resorbable bone growth promoting component 200 is resorbed into the newbone. Further, also detailed above, resorbable bone growth promotingcomponent 200 may also act as a carrier for providing various osteogenicgrowth factors and agents thereby aiding in the induction of new bonegrowth.

During regeneration of new bone, open porous metal component 100provides a matrix which supports bone ingrowth and mineralizationtherein as well as providing structural support to orthopaedic implant500, 500′ and bone B. Upon bone ingrowth within open porous metalcomponent 100, a rigid and secure secondary fixation of orthopaedicimplant 500, 500′ within bone is provided.

While configurations of orthopaedic implant 500, 500′ disclosed hereinhave been described and depicted in use for filling a void V, adjacent aprosthesis, in a femur and acetabulum, configurations of orthopaedicimplant 500, 500′ may be used for filling voids in other bones and voidsnot adjacent to a prosthesis. Additionally, although the configurationsof orthopaedic implant 500, 500′ depicted herein comprise only two orthree layers, configurations of orthopaedic implant 500 may includeadditional layers of either, or both, of open porous metal component 100and resorbable bone growth promoting component 200.

Exemplary Augment Embodiments of Orthopaedic Implants.

Referring to FIGS. 7, 8, and 9 a exemplary embodiments of orthopaedicimplant 600, 600′, 600″ are depicted for providing a support structure,or augment, for use with various prosthetic implants. As shown in FIGS.7, 8, and 9 a, the configurations of orthopaedic implant 600, 600′, 600″comprise multiple layers of each of open porous metal component 100, andresorbable bone growth promoting component 200, arranged in alternatinglayers.

The multiple layers of open porous metal component 100 and resorbablebone growth promoting component 200 comprising the configurations oforthopaedic implant 600, 600′, 600″ shown in FIGS. 7, 8, and 9 a arearranged such that orthopaedic implant 600, 600′, 600″ fills the void Vbetween the bone B and the prosthesis P, and such that orthopaedicimplant 600, 600′, 600″ contacts both bone B and prosthesis P.Advantageously, orthopaedic implant 600, 600′, 600″ provides a stablesupport (or augment) structure for prosthetic implants, and promotesbone regeneration around and, in some configurations, within theprosthetic implants.

Referring to FIG. 7, orthopaedic implant 600 is depicted as filling avoid V within the intramedullary canal C, and supporting a tibialbaseplate prosthesis P having stem S. As shown in FIG. 7, orthopaedicimplant 600 defines bore 602, allowing stem S of prosthesis P to beinserted therein. Also, as shown orthopaedic implant 600 may beorientated in void V such that portions of exposed porous surface 110 ofsome or all of the layers of open porous metal 100 contact bone B,thereby providing initial fixation for orthopaedic implant 600 withinvoid V.

Additionally, as discussed herein, configurations of orthopaedic implant600 may be combined with various bone growth factors or agents such asdiscussed herein. For example, one or more bone growth factors and/oragents can be injected or inserted into channels 104 of one or morelayers of open porous metal component 100 comprising orthopaedic implant600. Further, one or more growth factors and/or agents may be coated onone or more exposed porous surface 110 of the one or more layers of openporous metal 100.

Also, as discussed in detail above, one or more layer of resorbable bonegrowth promoting component 200 may be combined with one or more growthfactors and/or agents. While resorbable bone growth promoting component200 is depicted as a solid mass (compressed powder), orthopaedic implant600 may include one or more layers of resorbable bone growth promotingcomponent 200 comprising a soft mass. Further, resorbable bone growthpromoting component 200 may also be partially disposed within at least aportion of open porous metal component 100, such as illustrated in FIGS.3 and 4.

In some configurations, stem S of tibial baseplate prosthesis P may alsocomprise open porous metal 100. According to such configurations,regenerated bone may provide a secondary fixation of orthopaedic implant600 to stem S, thereby providing more natural and rigid support forprosthesis P and aiding in preventing degradation of bone adjacentorthopaedic implant 600 and prosthesis P.

Advantageously, during implantation, orthopaedic implant 600 may beshaped and sized according to a particular need. For example, a surgeonmay cut, trim, ream, and bend one or more layers of either or both ofresorbable bone growth promoting component 200 and open porous metalcomponent 100. Shaping and sizing of orthopaedic implant 600 may occurprior to or after assembling orthopaedic implant 600. A surgeon may alsoinsert orthopaedic implant 600 into canal C, and thereafter prepare bore602. As such, orthopaedic implant 600 may be used in place ofstandard-sized augments, thereby providing a customizable option forsupporting prosthetic implants which also promotes the regeneration ofnatural bone surrounding prosthesis P.

Referring to FIG. 8, another configuration of orthopaedic implant 600′is depicted, filling a void V within femoral canal C and supporting afemoral prosthesis P having stem S. As shown in FIG. 8, orthopaedicimplant 600″ also defines bore 602′, allowing stem S of prosthesis P tobe inserted therein. Also, similar to FIG. 7, orthopaedic implant 600′is orientated within void V such that portions of exposed porous surface110 of some or all the layers of open porous metal 100 contact bone B,thereby providing initial fixation of orthopaedic implant 600′ withinvoid V.

As with orthopaedic implant 600 (FIG. 7), orthopaedic implant 600′ maybe combined with one or more bone growth factors (either within thelayers of open porous metal component 100 or within resorbable bonegrowth promoting component 200). Also, one or more layers of resorbablebone growth promoting component 200 of orthopaedic implant 600′ maycomprise a soft mass composition as opposed to the solid mass(compressed powder) depicted in FIG. 8. Further, as with otherembodiments of the orthopaedic implants described herein, duringimplantation, orthopaedic implant 600′ may be shaped and sized accordingto a particular need.

Referring to FIG. 9 a, yet another configuration of orthopaedic implant600″ is depicted. Orthopaedic implant 600″ comprises three layers ofopen porous metal component 100 and two layers of resorbable bone growthpromoting component 200, arranged in multiple, alternating layers.Unlike the configurations of orthopaedic implant 600, 600′, shown inFIGS. 7 and 8, FIG. 9 a illustrates an exemplary embodiment oforthopaedic implant 600″ comprising a manufacturer-constructedconfiguration, which may be used in conjunction with commerciallyavailable prostheses, such as femoral stem 650 and distal femoralarticulating component 660, shown in FIG. 9 a.

As illustrated in FIG. 9 a, orthopaedic implant 600″ is configured tosecure femoral stem 650 which, in use, is implanted within the distalfemoral canal C of femur F, to distal femoral articulating component660. According to the configuration of orthopaedic implant 600″ shown inFIG. 9 a, distal segment 652 of femoral stem 650 fits within stemreceiving area 610 defined by orthopaedic implant 600″. Distal segment652 may be secured within stem receiving area 610 by compression fit, anadhesive, or a screw or the like. Further, in some configurations,femoral stem 650 may be comprised of open porous metal component 100,thereby allowing for femoral stem 650 and orthopaedic implant 600″ tobecome rigidly affixed by way of bone ingrowth.

Distal region 620 of orthopaedic implant 600″ is shaped and sized tosecurely attach to augment receiving section 662 of distal femoralarticulating component 660. For example, distal region 620 oforthopaedic implant 600″ may fit, and be secured within, augmentreceiving section 662 by way of compression fit, a screw, or anadhesive. Further, although distal region 620 of orthopaedic implant600″ is shown as comprising open porous metal component 100, in someconfigurations only certain portions of distal region 620 (such astissue contacting areas) will comprise open porous metal component 100.In such configurations, the non-open porous metal portions of distalregion 620 may comprise materials typically used in orthopaedic implantssuch as ceramics, titanium, and plastic alloys. Even further, someconfigurations of orthopaedic implant 600″ may include distal region 620being comprised completely of one or more materials typically used inorthopaedic implants.

Additionally, as with other configurations of the orthopaedic implantsdisclosed herein, orthopaedic implant 600″ may be combined with one ormore growth factors. Further, while orthopaedic implant 600″ isdescribed and depicted as a being preshaped and sized (for example by amanufacturer), in some configurations orthopaedic implant 600″ may stillbe modified by a surgeon during surgery. For example, a surgeon may beable to custom trim portions of orthopaedic implant 600″ during surgeryto provide a desired fit and shape for a specific patient need.

Referring again to FIGS. 7, 8, and 9 a, when implanted, the illustrativeconfigurations of orthopaedic implant 600, 600′, 600″ promote new boneregeneration through orthopaedic implant 600, 600′, 600″ and provideinitial structural support and fixation for prosthesis. As detailedabove, the layers of resorbable bone growth promoting component 200 (oforthopaedic implant 600, 600′, 600″) provide a temporary matrix for cellproliferation and extracellular matrix deposition, which also promotesvascularization for supporting continued bone regeneration andmaintenance. As new bone is regenerated, resorbable bone growthpromoting component 200 is resorbed into the new bone.

As detailed above, open porous metal component 100 aides in initialfixation of orthopaedic implant 600, 600′, 600″ with prosthesis P andbone B, and provides structural support for prosthesis P. Open porousmetal component 100 also provides a matrix which supports bone ingrowthand mineralization therein which, upon bone ingrowth therein, forms arigid and secure secondary fixation of orthopaedic implant 600, 600′,600″ to bone B and prosthesis P.

Further, as described herein, orthopaedic implant 600,600′, 600″ maybecombined with one or more bone growth factors or agents. For example,the osteoconductive carrier comprising resorbable bone growth promotingcomponent 200, and/or open porous metal 100, may be combined with one ormore bone growth factors or agents. Such configurations, uponimplantation, promote the initiation of osteogensis, thereby furtheraiding in the regeneration of bone and the fixation of natural bonethroughout orthopaedic implant 600, 600′, 600″.

Referring to FIG. 9 b, an illustrative embodiment of orthopaedic implant700 is presented. As with orthopaedic implant 600″ depicted in FIG. 9 a,orthopaedic implant 700 comprises a manufacturer-constructedconfiguration, which may be used in conjunction with commerciallyavailable prostheses, such as femoral stem S and distal femoral abutmentA shown in FIG. 9 a. However, unlike orthopaedic implant 600″ presentedin FIG. 9 a, orthopaedic implant 700 is entirely comprised of openporous metal component 100 with resorbable bone growth promotingcomponent 200 (comprising a soft mass) being disposed within channels104. Advantageously, orthopaedic implant 700 provides greater initialsupport for prosthesis P than provided by the configuration oforthopaedic implant 600″ shown in FIG. 9 a.

In some configurations, resorbable bone growth promoting component 200may be inserted into channels 104 of orthopaedic implant 700 by asurgeon prior to, or during surgery. Such configurations advantageouslypermit a surgeon to prepare resorbable bone growth promoting component200 to desired composition and concentration. In other configurations oforthopaedic implant 700, resorbable bone growth promoting component 200may constitute a powder, or putty-like composition, which is insertedinto channels 104 during manufacture. Such configurations may then becombined with a desired liquid, such as bone marrow aspirate, bloodplasma, or other mixtures as disclosed herein. Further, while shown inFIG. 9 b as being disposed within only a portion of channels 104 oforthopaedic implant 700, resorbable bone growth promoting component 200may be disposed throughout all, or substantially all, channels 104 oforthopaedic implant 700.

Additionally, as described herein, orthopaedic implant 700 may becombined with one or more growth factors or agents. For example, asdescribed herein, resorbable bone growth promoting component 200(disposed within channels 104 of open porous metal component 100) mayhave one or more growth factors embedded therein. Such configurations,upon implantation, promote the initiation of osteogensis throughout openporous metal component 100 comprising orthopaedic implant 700.

When implanted, orthopaedic implant 700 promotes new bone regenerationthroughout channels 104 and provides structural support and fixation forthe bone, joint or other prosthesis components. As detailed above,resorbable bone growth promoting component 200 (disposed throughoutchannels 104 of open porous metal component 100 comprising orthopaedicimplant 700) provides a temporary matrix for cell proliferation andextracellular matrix deposition. Further, resorbable bone growthpromoting component 200 promotes vascularization (throughout orthopaedicimplant 700) for supporting continued bone regeneration and maintenance.As new bone is regenerated, resorbable bone growth promoting component200 is resorbed into the new bone, which is ingrown within channels 104of orthopaedic implant 700, thereby creating a rigid, solid affixationof the surrounding bone to orthopaedic implant 700.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. An orthopaedic implant for treating a bone void,comprising: an open porous metal component; and a resorbable bonegrowth-promoting component, said open porous metal component including afirst porous metal layer spaced apart from a second porous metal layerby a first layer of said resorbable bone growth-promoting component,said first layer of said resorbable bone growth-promoting componentcontacting said first porous metal layer and said second porous metallayer.
 2. The orthopaedic implant of claim 1, wherein each of said firstporous metal layer and said second porous metal layer comprises acoefficient of friction which is greater than said resorbable bonegrowth-promoting component and mammalian bone tissue.
 3. The orthopaedicimplant of claim 1, wherein each of said first porous metal layer andsaid second porous metal layer includes a plurality of channels thereinwith material from said first layer of said resorbable bonegrowth-promoting component infiltrating the plurality of channels ineach of said first porous metal layer and said second porous metallayer.
 4. The orthopaedic implant of claim 1, further comprising animplantable prosthesis with an elongate stem component traversing saidfirst porous metal layer and said second porous metal layer such thatsaid first porous metal layer and said second porous metal layer aregenerally transverse to a longitudinal axis of said elongate stemcomponent.
 5. The orthopaedic implant of claim 4, wherein said elongatestem component is a stem component of a knee, hip or shoulderprosthesis.
 6. The orthopaedic implant of claim 5, wherein said elongatestem component is a stem component on the tibial side of a kneeprosthesis.
 7. The orthopaedic implant of claim 4, wherein said elongatestem component includes an open porous metal outer surface.
 8. Theorthopaedic implant of claim 4, wherein each of said first porous metallayer and said second porous metal layer is generally annular so as toprovide a passage through which said elongate stem component extends. 9.The orthopaedic implant of claim 8, wherein said generally annular firstporous metal layer and said generally annular second porous metal layerare of a different circumference providing a generally conicalaugmenting body around said elongate stem component.
 10. An orthopaedicimplant, comprising: an implantable prosthesis that includes an elongatestem component; and a three-dimensional augment body providing anelongate passage into which said elongate stem component can be receivedfor augmenting said implantable prosthesis, said three-dimensionalaugment body incorporating a plurality of stacked layers which includesa first open porous metal layer, a second open porous metal layer, and aresorbable bone growth-promoting layer situated between said first openporous metal layer and said second open porous metal layer.
 11. Theorthopaedic implant of claim 10, wherein a top face of said resorbablebone growth-promoting layer contacts a bottom face of said first openporous metal layer and a bottom face of said resorbable bonegrowth-promoting layer contacts a top face of said second open porousmetal layer.
 12. The orthopaedic implant of claim 10, wherein saidaugment body is generally concial.
 13. The orthopaedic implant of claim10, wherein said augment body is generally cylindrical.
 14. Theorthopaedic implant of claim 10, wherein said elongate passage isblind-ending in said three-dimensional augment body.
 15. A method ofimplanting an orthopaedic implant, comprising: positioning athree-dimensional augment body in a bone with an elongate stem componentof an implantable prosthesis received in an elongate passage in thethree-dimensional augment body, wherein said three-dimensional augmentbody incorporates a plurality of stacked layers which includes a firstopen porous metal layer spaced from a second open porous metal layer,and wherein said elongate stem component includes an open porous metalouter surface and traverses said first open porous metal layer and saidsecond open porous metal layer.
 16. The method of claim 15, wherein aresorbable bone growth-promoting layer is situated between said firstopen porous metal layer and said second open porous metal layer.
 17. Themethod of claim 15, wherein said three-dimensional augment body ispositioned in the bone before the elongate stem component of theimplantable prosthesis is received in said elongate passage.
 18. Amethod of implanting an orthopaedic implant, comprising: positioning amultilayered malleable sheet in a bone void with a first face of themalleable sheet contacting walls of the bone void and a second face ofthe malleable sheet remaining exposed for contacting an implantableprosthesis that is subsequently implantable adjacent the bone void,wherein said multilayered malleable sheet incorporates a first openporous metal layer spaced from a second open porous metal layer; andlocating an implantable prosthesis adjacent the bone void so as tocontact the exposed second face of the malleable sheet.
 19. The methodof claim 18, wherein a first resorbable bone growth-promoting layer issituated between said first open porous metal layer and said second openporous metal layer.
 20. The method of claim 18, wherein the implantableprosthesis includes an open porous metal outer surface.
 21. The methodof claim 18, wherein a second resorbable bone growth-promoting layerprovides the first face of the multilayered malleable sheet.
 22. Anorthopaedic implant, comprising: a monolithic open porous metal bodydefining a plurality of channels therein and having an exposed porousexterior surface for contacting bone; and a resorbable bonegrowth-promoting component comprising an osteoinductive carrier and atleast one bone growth factor, said resorbable bone growth-promotingcomponent being disposed within said plurality of channels of saidmonolithic open porous metal body.
 23. The orthopaedic implant of claim22, wherein said resorbable bone growth-promoting componentsubstantially fills said plurality of channels of said monolithic openporous metal body.